Data quality framework for medicines regulation

• Date:
  Thursday, 07 April 2022, 13:00 (CEST) - 17:15 (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

On 7 April 2022 the Agency will host joint EMA/HMA/TEHDAS Data Quality Framework workshop.

One of the Priority Recommendations of the HMA-EMA joint Big Data Task Force is to establish an EU framework for data quality that will support the trust of patients and healthcare professionals in the decisions reached by regulators, when various types of data underpin those decisions.
This workshop seeks to engage stakeholders early in the drafting process of an EU Network data quality framework, to ensure a robust starting point, in line with their expectations and needs.
The main objectives of the workshop are to:

• Engage stakeholders in a discussion on the content (e.g.: topics, table of contents) and approach to a Data Quality Framework, according to their needs
• Collect input from experts in the field and learn from existing experiences
• Prioritise use cases to focus an in-depth analysis

The Data Quality Framework workshop will be held as a virtual meeting. Attendance is organised via EU associations and direct invitations, allowing a broad range of stakeholders to participate.
The meeting will be broadcast live on this web page and a video recording will be made available afterwards. No registration is required to view the live broadcast.

Documents

Agenda - Data quality framework for medicines regulation

DraftReference Number: EMA/172989/2022

Report - Data quality framework for medicines regulation

Reference Number: EMA/615349/2022

Presentation - Opening remarks (P. Bachmann, BfArM)

Presentation - Analyses of Data Quality Frameworks (P. Alcini, EMA)

Presentation - Maturity Model for Medical Device Registries and Coordinated Registry Networks (CRNs) (D. Marinac-Dabic, FDA/CDRH)

Presentation - Building a data quality framework for the European Health Data Space on Secondary Use (E. Bernal-Delgado, IACS)

Presentation - Quality Control Systems for Secondary Use Data (P. Berzin, Odysseus)

Presentation - Preparation for breakout sessions (P. Alcini, EMA)

Presentation - Drafting a data quality framework structure (C. Reich, IQVIA)